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NCT01140191 · ClinicalTrials.gov registry record · Phase 2

Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis

A Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT01140191: Clinical Trial Phase 2 study, sponsored by U.S. Army Medical Research and Development Command.

NCT01140191 is a Phase 2 study that was terminated before completion, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01140191, a Phase 2 study, was terminated before completion, sponsored by U.S. Army Medical Research and Development Command.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study Summary

The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).

Primary Outcome

Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs

Interventions

  • DRUG WR 279,396

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2013-09
Est. Completion 2014-09
Phase Phase 2

Why NCT01140191 stopped before completion

NCT01140191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which WR 279,396 is the first listed.

NCT01140191 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01140191 about?

NCT01140191 is a clinical study titled "Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis". The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).

What is the current status of trial NCT01140191?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2013-09. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01140191?

The interventions under investigation include: WR 279,396 (DRUG).

Who is sponsoring clinical trial NCT01140191?

This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01140191's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01140191, the US trial registry maintained by the National Library of Medicine. NCT01140191 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.